In re LCD Complaint of Kathleen A. Oler, DAB CR6054 (2022)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

The Civil Remedies Division of the Departmental Appeals Board received correspondence from Kathleen A. Oler dated February 7, 2022.  Based on the contents of the letter and the accompanying documents, it appeared Ms. Oler challenged a local coverage determination (LCD) regarding the PureWick System. I was designated to review her LCD challenge.  

I. Background

Upon initial review, I construed Ms. Oler’s letter as an LCD Complaint and concluded she was an aggrieved party within the meaning of the regulation. 42 C.F.R. § 426.110.  Based on the documentation she submitted, it appeared Ms. Oler filed her challenge after receiving the service. But while Ms. Oler’s hearing request included a prescription for the PureWick System dated May 29, 2021, she did not provide an initial denial notice indicating she submitted a Medicare claim for coverage that was denied by one of CMS’s administrative contractors. I was therefore unable to determine whether Ms. Oler had timely filed her complaint within 120 days of the initial notice of denial of the requested service as required by 42 C.F.R. § 426.400(b).  

Even assuming timely filing, however, I concluded Ms. Oler had not filed an otherwise acceptable and valid LCD complaint under the applicable regulations. See 42 C.F.R. § 426.410(b). Therefore, on February 10, 2022 I issued an Acknowledgment of Receipt and Order to Amend Unacceptable Complaint (Order to Amend).  In that order, I informed Ms. Oler that her initial complaint was deficient and provided her one opportunity to submit an acceptable complaint. See 42 C.F.R. § 426.410(c)(1).

My Order to Amend set forth the necessary elements of a LCD complaint, which are also found at 42 C.F.R. § 426.400. I explained Ms. Oler’s initial attempt to file a valid complaint failed because it did not provide the following information:

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• LCD identifying information:  Ms. Oler did not identify the LCD, the name of the Contractor that applied the LCD, the title of the LCD she challenges, or the specific provision or provisions of the LCD adversely affecting her.
• Aggrieved party statement:  Ms. Oler did not submit a statement explaining why she thinks that the LCD provision she is challenging is not valid under the reasonableness standard.
• Clinical or scientific evidence:  Ms. Oler did not provide copies of clinical or scientific evidence in support of her complaint. Nor did she explain why she believes that such evidence shows that the LCD is not reasonable.

My Order to Amend directed Ms. Oler to file an amended complaint that corrected these deficiencies by March 17, 2022. I advised Ms. Oler that if she did not submit an acceptable amended complaint in that time, I would issue a decision dismissing this action.  42 C.F.R. § 426.410(c)(2).

Ms. Oler timely responded to my Order to Amend and attempted to correct the above-identified deficiencies by providing a written statement. DAB E-File Dkt. No. C 22 302, Doc. No. 3. In her statement, Ms. Oler contends she does not wish to appeal a denied claim but instead challenges the lack of reimbursement by the Medicare program for the PureWick System. Id. at 1.  Ms. Oler explains that her treating urologist believes she needs the PureWick System and that it is effective. Id. at 1-3. Ms. Oler also states that she had not filed a claim for coverage with the Medicare program because she “knows Medicare does not recognize the PureWick System as medically necessary durable equipment.” Id. at 4.  

II. Discussion

Where an aggrieved party files an unacceptable LCD complaint and fails to submit an acceptable amended complaint within a reasonable timeframe, I am required to dismiss the complaint.  42 C.F.R. § 426.410(c)(2).  For a complaint to be acceptable, it must meet the requirements set forth in 42 C.F.R. § 426.400.  42 C.F.R. § 426.410(b)(2). 

Ms. Oler’s initial LCD complaint was insufficient. Without an initial denial notice from CMS or one of its contractors, I could not determine whether Ms. Oler had timely filed her complaint. 42 C.F.R. § 426.400(b). Ms. Oler’s initial filing otherwise failed to meet three requirements for a valid complaint. She did not identify the LCD, the name of the Contractor which applied the LCD, the title of the LCD she challenges, or the specific provision or provisions of the LCD adversely affecting her. 42 C.F.R. § 426.400(c)(4). Ms. Oler also failed to provide a statement in her initial filing explaining why she believes that the LCD provision she is challenging is not valid under the reasonableness

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standard. Finally, Ms. Oler did not provide clinical or scientific evidence to demonstrate a LCD is not reasonable. 42 C.F.R. § 426.400(c)(5), (6)(i).

I therefore provided Ms. Oler one opportunity to amend her complaint in order to correct the deficiencies I identified to her. She timely filed an amended complaint.  However, while I recognize Ms. Oler made an effort in good faith to amend her complaint to satisfy the regulatory requirements I identified, I must find her amended complaint unacceptable.

In my Order to Amend, I directed Ms. Oler to identify an applicable LCD in her amended complaint. However, Ms. Oler failed to provide any LCD identifying information in her amended complaint and instead asserts she did not file a claim for coverage. Because she has not submitted a claim for coverage that was denied based on an LCD, Ms. Oler is not an aggrieved party within the meaning of the regulation.

Even if Ms. Oler is an aggrieved party under the regulation, Ms. Oler has not provided sufficient evidence for me to conclude that her initial complaint was timely.  n her amended complaint, Ms. Oler explains she chose not to appeal sooner because she wanted to ensure the PureWick System would be effective. Because Ms. Oler already received the service, she was required to file a complaint within 120 days of the date of the initial notice of denial of coverage by CMS or one of its contractors. However, as Ms. Oler states, she never filed a claim and does not have an initial denial notice. Therefore, I am unable to conclude that her complaint was timely.

Ms. Oler’s amended complaint otherwise fails to satisfy the requirements for a valid LCD complaint under 42 C.F.R. § 426.400(c).  It fails to provide any LCD identifying information, including the name of the contractor using the LCD, title of the LCD, or specific provisions of a LCD affecting Ms. Oler.  See 42 C.F.R. § 426.400(c)(4). Furthermore, although Ms. Oler identifies a specific treatment she believes should be covered, she did not explain why she thinks that the provision(s) of an applicable LCD policy is (are) not valid under the reasonableness standard. See 42 C.F.R. § 426.400(c)(5).

Finally, Ms. Oler has not provided sufficient clinical or scientific evidence in support of her complaint. To satisfy the requirement for submission of clinical and scientific evidence imposed by the regulations, Ms. Oler relies on medical records from her treating urologist that she submitted with her complaint. The plain language of the governing regulations does not explicitly preclude the submission of an individual’s own personal medical records. They merely require submission of “[c]opies of clinical or scientific evidence that support the complaint and an explanation for why the aggrieved party thinks that this evidence shows that the LCD is not reasonable.” 42 C.F.R. § 426.400(c)(6).

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But while the regulation references clinical evidence, it does not appear the drafters of the LCD challenge regulations intended an individual’s personal medical records to satisfy this requirement. The LCD challenge process is separate and distinct from the claims appeal process that individual beneficiaries use to appeal denial of coverage of a procedure by Medicare. 42 C.F.R. § 426.310(a) (“LCD . . . reviews are distinct from the claims appeal processes set forth in [42 C.F.R.] part 405, subparts G and H; [42 C.F.R.] part 417, subpart Q; and [42 C.F.R.] part 422, subpart M . . ..”).

As the drafters explained in the preamble to the final LCD rule, the individual Claims Appeal Process allows a beneficiary of the Medicare program to challenge such denials and eventually receive review from an independent administrative law judge (ALJ); that appeals process “enables beneficiaries to submit any relevant information pertaining to an individual claim.” 68 Fed. Reg. 63,692, 63,693 (Nov. 7, 2003) (emphasis added).1 An ALJ in that context could rely on a beneficiary’s own medical evidence to find application of an LCD unpersuasive and pay an individual claim without any need to overturn the LCD itself. Id.

By contrast, the LCD Review Process is different “because the nature of the challenge and the relevant evidence is different.” Id. Rather than determining whether the LCD can be reasonably applied to one individual, as the Claims Appeals Process allows, adjudication of an LCD challenge “requires examination of an entire policy, or specific provisions contained therein, and not just one claim denial. Therefore, such reviews may lead to changes that impact other beneficiaries if the policies are found to be unreasonable.” Id.

In that context, the regulatory requirement to provide “clinical and scientific evidence” is clearly intended to require the aggrieved party to provide evidence showing the entire LCD policy is unreasonable, not that it is improperly applied to him or her. This suggests such evidence is more likely newfound data emanating from clinical or scientific studies that supports a change in the medical premises undergirding an LCD policy.2

But even allowing for the possibility of using individual medical records to meet the clinical and scientific evidence requirement necessary to challenge an LCD, Ms. Oler did not identify an LCD or explain why her medical records demonstrate application of an LCD is unreasonable. Nor can I say on my own review that the medical records submitted by Ms. Oler are adequate to do so. In fact, her records do not appear to support

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a challenge to the application of any relevant LCD policy. As such, Ms. Oler’s request for coverage of the PureWick System prescribed by her doctor would more properly be raised in an individual claim determination, not a general LCD challenge.

III. Conclusion

Ms. Oler is not an aggrieved party within the meaning of the regulation because she has not submitted a claim for coverage that was denied based on an applicable LCD. Her amended complaint does not include the required LCD identifying information or a statement from Ms. Oler explaining why an applicable LCD is not valid under the reasonableness standard. Finally, Ms. Oler’s medical records do not constitute clinical or scientific evidence that supports her complaint under 42 C.F.R. § 426.400(c)(6)(i). Ms. Oler’s complaint remains unacceptable under 42 C.F.R. § 426.410(b).  I must therefore dismiss this complaint. 42 C.F.R. § 426.410(c)(2). 

1. The Civil Remedies Division does not hear such individual claims, which are instead heard by ALJs in the Office of Medicare Hearings and Appeals.
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2. The regulation requiring submission of clinical or scientific evidence reinforces this view, as it contemplates protecting proprietary data in such submissions, such as data submitted to the FDA. 42 C.F.R. § 426.400(c)(i),(ii).
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